This page provides an independent statistical analysis and educational interpretation of publicly reported results. ClinicalTrials.gov provides the official trial registry record. Numerical trial results on this page are restricted to the results posted in the ClinicalTrials.gov record; calculations added by Clinical Biostats are labelled as such.
1. Trial at a Glance
This page covers the registry results for Evaluation of Safety, Efficacy, Pharmacokinetic and Pharmacodynamic of Bertilimumab in Patients With Active Moderate to Severe Ulcerative Colitis (NCT01671956), a randomized phase 2 study. The primary outcome is Change From Baseline in Total Mayo Score at Day 56.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT01671956 |
| Phase | Phase 2 |
| Condition | Ulcerative Colitis, Active Moderate, Ulcerative Colitis, Active Severe |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Quadruple |
| Enrollment | 32 |
| Arms in the primary outcome | 2 |
| Lead sponsor | Alexion Pharmaceuticals, Inc. |
| Results posted | Yes |
2. Clinical Question
Population
Adults with active moderate to severe ulcerative colitis were the population of interest. The registry describes a modified intent-to-treat analysis set: randomized participants who received at least one dose of bertilimumab or placebo, had a full Mayo score at screening, and had at least one post-baseline partial Mayo score from visit 3 onwards. The primary outcome summary includes 14 participants in the bertilimumab arm and 6 in the placebo arm. The registry record does not explain the difference between those outcome counts and the randomized enrollment.
Intervention
Bertilimumab was administered by intravenous infusion over 30 minutes at 10 mg/kg, according to the arm description. The trial title and summary frame the study as an evaluation of safety, efficacy, pharmacokinetic, and pharmacodynamic characteristics. The registry lists the trial as phase 2.
Comparator
The comparator was placebo: phosphate buffered saline administered by intravenous infusion over 30 minutes. The study was randomized, double-blind, placebo-controlled, parallel-group, and multicenter. The registry identifies quadruple masking but does not specify in the record what roles were masked.
Primary question
The primary endpoint asked how the Total Mayo score changed from baseline to Day 56 in the two arms. The registry posts a value of 2.7 for bertilimumab and 2.5 for placebo, with full ranges of 0.0 to 8.0 and 1.0 to 6.0, respectively. These are descriptive summaries; the registry record contains no posted analysis entries comparing the arms. The termination reason and the rationale for stopping are not reported in the registry record.
3. Trial Design
The registry identifies NCT01671956 as a phase 2, randomized, quadruple-masked, parallel-group trial. Its title describes a multicenter, double-blind, placebo-controlled study of bertilimumab in active moderate to severe ulcerative colitis. The brief summary specifies adult participants. Enrollment is listed as 32, and the study status is terminated. The registry lists a start date of 2015-07-31 and a primary completion date of 2018-08-31. The reason for termination is not reported in the registry record.
Participants were assigned to bertilimumab or placebo. The bertilimumab arm description specifies 10 mg/kg by intravenous infusion over 30 minutes. The placebo was phosphate buffered saline, also given by intravenous infusion over 30 minutes. Although the record calls the trial quadruple-masked, it does not say which groups of people were masked, or describe the procedures used to maintain masking.
The primary outcome was change from baseline in Total Mayo score at Day 56. The registry also lists change from baseline in Ulcerative Colitis Endoscopic Index of Severity (UCEIS) score at Day 56 as a secondary outcome. Two outcome measures are recorded, but no analysis entries are posted. The record does not provide an explanation of the termination, nor does it report the rationale for the enrollment target, a sample-size justification, or a statistical analysis plan.
The primary outcome summaries use 14 participants in the bertilimumab arm and 6 in the placebo arm. Those counts are not the same as the listed enrollment, and the registry record does not explain the relationship between enrollment and the analyzed outcome populations. The safety summaries use different numbers at risk for each arm. These populations should be kept distinct when reading the results; the record does not establish that they have identical eligibility or follow-up.
4. Participant Flow and Accounting
The registry reports how participants moved through each stage of the study. All counts below are exactly as posted; missing counts are not inferred from other stages.
Before assignment: The study was initiated in Jul 2015 and was early terminated due to sponsor decision.
Overall Study
| Stage | Bertilimumab | Placebo |
|---|---|---|
| STARTED | 20 | 12 |
| Received at Least 1 Dose of Study Drug | 20 | 12 |
| COMPLETED | 18 | 10 |
| NOT COMPLETED | 2 | 2 |
Reasons for not completing this period:
| Reason | Bertilimumab | Placebo |
|---|---|---|
| Disease progression | 0 | 1 |
| Withdrawal by Subject | 1 | 1 |
| Adverse Event | 1 | 0 |
Analysis population for the primary outcome, as defined in the registry: The modified intent to treat (mITT) analysis set included all randomized participants who received at least one dose of study treatment (placebo or bertilimumab) and had at least a full Mayo score at screening and at least one post-baseline partial Mayo score from visit 3 onwards. Here, overall number of participants analyzed signifies those participants who were evaluable for this outcome measure.
5. Baseline Characteristics
The table reproduces the baseline characteristics posted in the registry, which describe the participants analysed at baseline and help show whether the randomized groups were comparable.
Population: The safety analysis set included all participants who were exposed to any of the study treatments.
| Characteristic | Unit | Bertilimumab | Placebo | Total |
|---|---|---|---|---|
| Participants analysed | 20 | 12 | 32 | |
| Age, Categorical: <=18 years | Participants | 0 | 0 | 0 |
| Age, Categorical: Between 18 and 65 years | Participants | 19 | 12 | 31 |
| Age, Categorical: >=65 years | Participants | 1 | 0 | 1 |
| Sex: Female, Male: Female | Participants | 9 | 7 | 16 |
| Sex: Female, Male: Male | Participants | 11 | 5 | 16 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Asian | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Black or African American | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): White | Participants | 20 | 12 | 32 |
| Race (NIH/OMB): More than one race | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 0 | 0 | 0 |
6. Primary Endpoint
The registry lists the primary outcome as Change From Baseline in Total Mayo Score at Day 56, measured over Baseline, Day 56.
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | Full Range |
| Unit | scores on a scale |
| Endpoint classification | not reduced to a single comparison |
The primary endpoint was change from baseline in Total Mayo score at Day 56. The Total Mayo score is described as a measure of ulcerative colitis disease activity, ranging from 0, denoting normal or inactive disease, to 12, denoting severe disease. It combines the stool-frequency, rectal-bleeding, endoscopic-finding, and physician’s-global-assessment sub-scores. Each sub-score ranges from 0 to 3, and the sub-scores are summed.
A composite score can bring several aspects of a condition into one outcome, which can be useful when a study aims to represent overall disease activity rather than a single symptom or finding. In general, a change-from-baseline endpoint compares a participant’s score at follow-up with the score at the start of the relevant assessment period. The registry specifies that the endpoint is assessed from baseline to Day 56.
The registry describes its calculation as the sum of Day 56 scores minus the sum of baseline scores, divided by 14 for bertilimumab and by 6 for placebo. It reports a value of 2.7 for bertilimumab and 2.5 for placebo. The accompanying full ranges are 0.0 to 8.0 and 1.0 to 6.0, respectively. These summaries alone do not give the uncertainty around either arm’s value or an inferential comparison between arms. The registry record does not report confidence intervals or a statistical test for this primary outcome.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The posted primary outcome values are 2.7 for bertilimumab and 2.5 for placebo. The record labels the endpoint as a mean change from baseline in Total Mayo score at Day 56. It gives full ranges of 0.0 to 8.0 for bertilimumab and 1.0 to 6.0 for placebo. These are descriptive arm-level results, not an estimated treatment contrast. No confidence interval, standard error, or p-value for an arm comparison is reported in the registry record.
The reported outcome counts are 14 for bertilimumab and 6 for placebo. They should be read as the numbers associated with the posted outcome summaries, not as the enrollment in the trial. The record lists enrollment as 32 but does not explain why the outcome counts are smaller. The modified intent-to-treat criteria are described, but the registry does not state how many randomized participants failed each criterion, how many had missing Day 56 measurements, or how such missing measurements were handled.
The full range describes the lowest and highest observed values in the reported group; it is not a confidence interval. A range can show that observations varied, but it does not quantify the precision of the group mean in the way an interval estimate would. Without a standard deviation, standard error, or confidence interval, the precision of the two displayed mean values cannot be assessed from these summaries. The values also do not show how individual participant scores changed.
There is no posted inferential analysis entry in the registry. Therefore, the posted figures do not establish whether the observed arm summaries are compatible with chance variation under a specified comparison model. They also do not provide an adjusted effect estimate, a prespecified superiority test, or a conclusion based on a reported statistical analysis. The registry record does not report the planned statistical model or its assumptions.
In general, an arm-by-arm descriptive comparison is not equivalent to a randomized treatment-effect estimate. A direct contrast would need to account for the trial’s analysis population and the planned approach to missing data, among other design details. It would also need a measure of uncertainty. None of those inferential details is posted for this endpoint. The difference between the two values should not be calculated or treated as a formal effect estimate.
The record’s endpoint description gives different divisors for the two arms: 14 for bertilimumab and 6 for placebo. Those divisors match the respective outcome counts listed in the arm summaries. The record does not give additional detail on participant-level calculation or aggregation beyond this description. This makes it important to present the values as registry-reported summaries, rather than infer a different calculation or reconstruct individual data.
The results should also be interpreted in light of the trial status. The study is listed as terminated, but the reason is not reported in the registry record. The status alone does not explain the posted outcome counts or indicate why the study ended. Nor does the record establish whether termination affected the timing, completeness, or analysis of the primary outcome.
9. Statistical Methods Explained
The registry describes a randomized, quadruple-masked, parallel-group study with bertilimumab and placebo arms. Random allocation is generally intended to reduce systematic differences between groups at the point of assignment. In general, masking can reduce the influence of treatment knowledge on participant experience, clinical management, outcome assessment, or analysis. The record does not specify who was masked or how allocation and masking were implemented, so their practical operation cannot be evaluated from this information.
The primary outcome is a change-from-baseline summary, and the endpoint description identifies the Total Mayo score as a composite. In general, a composite can represent several related dimensions of a clinical condition in a single measure. Its interpretation depends on how its components are defined and combined. Here, the registry states that four sub-scores are summed, with each scored from 0 to 3 and the total ranging from 0 to 12. It specifies assessment at baseline and Day 56. The registry reports the arm values and full ranges, but not participant-level observations or a measure of variability beyond those ranges.
The outcome is labeled as a mean, with full range as the dispersion summary. A mean describes the central value of observations on a numerical scale. A range describes the endpoints of the observed values. In general, neither the mean nor the range alone shows how observations are distributed between those endpoints. Ranges can also be influenced by extreme observations. The registry record does not report a standard deviation, standard error, or confidence interval for this outcome, so the precision of the arm means cannot be judged from the posted summaries.
In general, a confidence interval is a range of values constructed by a statistical procedure to express uncertainty around an estimate. It is useful because an effect estimate without uncertainty can give an incomplete picture of how precisely the data distinguish among plausible values. No confidence interval is reported for the primary endpoint. The record also contains no posted test statistic or p-value for an arm comparison. Thus, the primary results are descriptive, and statistical evidence for a between-arm difference cannot be assessed from the record.
Different statistical models can be used to estimate a treatment contrast. Their suitability depends on the outcome scale, study design, analysis population, and data features. The registry record does not report a model for the primary outcome, any adjustment variables, or a statistical analysis plan. It is therefore not possible to determine whether the posted values were intended as a final analysis, whether any covariate adjustment was planned, or how the analysis would account for repeated or incomplete measurements. These details are not reported in the registry record.
For a randomized trial, a direct contrast is ordinarily the quantity that addresses how outcomes differ between assigned groups under a specified analysis. General approaches may compare endpoint values or compare changes from baseline, and may use adjusted or unadjusted models. Which approach is appropriate depends on the prespecified analysis and available data. The registry gives arm-specific endpoint summaries but does not report a contrast or identify the intended comparison method. No recalculated comparison is posted, and there is no basis in this record for constructing a valid inferential estimate from the group means and ranges alone.
Missing data are especially relevant to change-from-baseline outcomes because both baseline and follow-up information contribute to the endpoint. In general, missingness can affect the population represented by an analysis and can introduce bias if the reasons for missing measurements are related to outcome values. Different assumptions and methods for handling missing data can lead to different estimates. The registry describes the modified intent-to-treat analysis set, but does not report the amount or pattern of missing primary-outcome data, the reasons for missingness, or the method used to handle it.
The primary outcome analysis population is described as randomized participants who received at least one dose of study treatment, had a full Mayo score at screening, and had at least one post-baseline partial Mayo score from visit 3 onwards. This is the registry’s stated modified intent-to-treat definition. It is not the same as a statement that all randomized participants were included in the primary analysis. The registry lists enrollment as 32 and the primary outcome counts as 14 and 6 by arm, without explaining how participants were included or excluded between those descriptions.
The registry’s sample-size assumptions describe planning illustrations based on the observed effect, with a two-sided significance level of 0.05, equal allocation, and a normal approximation. These illustrations use fractions of the observed effect as planning scenarios. In general, such calculations estimate the participants per arm that would be needed under the stated assumptions for a specified power target. They are planning illustrations, not observed power and not evidence that the original trial was designed with those assumptions. The registry record does not report the trial’s own sample-size justification, and the planning assumptions do not replace a posted treatment-effect analysis.
Over-dispersion is a general statistical issue that arises when observed variability is greater than a model assumes. If a model understates variability, its uncertainty estimates may be too narrow and its tests may be misleading. The registry does not report a model for this endpoint or evidence that over-dispersion was assessed; this is therefore a general consideration, not a reported feature of this trial’s analysis. Similarly, no assumption checks or sensitivity analyses are reported.
The registry lists one secondary outcome: change from baseline in UCEIS score at Day 56. It records two outcome measures and zero analysis entries. In general, when several outcomes or comparisons are tested, multiplicity can increase the chance of a false-positive finding across the collection of tests. Statistical plans may address this through prespecified hierarchies or adjustments. The registry record does not report whether such methods were planned. With no posted inferential tests, there is no reported multiplicity adjustment to interpret.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists the primary Total Mayo score outcome and one secondary outcome, change from baseline in UCEIS score at Day 56. It records two outcome measures but zero analysis entries. The primary outcome has descriptive arm summaries; no inferential analysis is posted. No adjustment for multiple outcomes or tests, testing hierarchy, or multiplicity strategy is reported in the registry record.
In general, testing multiple outcomes can increase the probability of at least one apparently positive result by chance. A prespecified analysis plan can define which outcome is primary and how secondary outcomes are interpreted or adjusted. Here, the primary and secondary outcomes are identified, but the statistical plan and any multiplicity procedure are not reported. The registry record does not provide a basis for judging whether any intended analysis controlled multiplicity.
The modified intent-to-treat set is defined as randomized participants who received at least one dose, had a full Mayo score at screening, and had at least one post-baseline partial Mayo score from visit 3 onwards. The record gives the primary outcome counts by arm, but does not report the number of participants excluded from this set, the reasons for exclusion, or how missing Day 56 scores were handled. It also does not report imputation, sensitivity analyses, or a comparison of included and excluded participants.
In general, missing-data methods require assumptions about why values are missing and how missing outcomes relate to observed information. Because those assumptions and methods are not reported, the robustness of the primary endpoint summaries to missing data cannot be assessed from the registry record. The difference between listed enrollment and the outcome counts remains unexplained.
11. Safety Results
The registry reports serious adverse events as affected participants divided by participants at risk.
| Arm | Participants with serious adverse events | Participants at risk | Percentage |
|---|---|---|---|
| Bertilimumab | 2 | 20 | 10.0% |
| Placebo | 1 | 12 | 8.3% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Bertilimumab | 0 of 20 |
| Placebo | 0 of 12 |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 0% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Bertilimumab | 14 of 20 |
| Placebo | 5 of 12 |
Most frequent serious adverse event terms
| Event term | Organ system | Bertilimumab | Placebo |
|---|---|---|---|
| Hypersenstivity | Immune system disorders | 1 of 20 | 0 of 12 |
| Anal squamous cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 0 of 20 | 1 of 12 |
| Diarrhea | Gastrointestinal disorders | 1 of 20 | 0 of 12 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Bertilimumab | Placebo |
|---|---|---|---|
| Infusion related reaction | Injury, poisoning and procedural complications | 3 of 20 | 1 of 12 |
| Nasopharyngitis | Infections and infestations | 2 of 20 | 1 of 12 |
| Headache | Nervous system disorders | 1 of 20 | 2 of 12 |
| Back pain | Musculoskeletal and connective tissue disorders | 1 of 20 | 1 of 12 |
| Pyrexia | General disorders | 0 of 20 | 2 of 12 |
| Abdominal pain | Gastrointestinal disorders | 2 of 20 | 0 of 12 |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | 1 of 20 | 1 of 12 |
| Dizziness | Nervous system disorders | 1 of 20 | 1 of 12 |
| Dysgeusia | Nervous system disorders | 0 of 20 | 1 of 12 |
| Pruritus | Skin and subcutaneous tissue disorders | 0 of 20 | 1 of 12 |
Serious events with the highest arm-level rate: anal squamous cell carcinoma (8.3%), hypersenstivity (5.0%), diarrhea (5.0%).
The safety record lists serious adverse event counts by arm and gives separate numbers at risk. For bertilimumab, 20 participants are listed as at risk and 2 as affected by a serious adverse event. For placebo, 12 are listed as at risk and 1 as affected. The record lists 0 deaths in each arm. These are safety summaries, and their denominators should not be conflated with the primary outcome counts of 14 and 6.
In general, a count of participants with at least one serious adverse event is different from a count of all serious events, because a participant may experience more than one event. The registry’s figures are presented as affected-participant counts; the record does not give event-level timing, duration, severity details, or a treatment-relatedness assessment for each affected participant. The record does not explain the difference between the safety populations and the primary outcome populations.
The registry also lists serious-event terms and percentages: Anal squamous cell carcinoma, 8.3%; Hypersenstivity, 5.0%; and Diarrhea, 5.0%. It does not make clear in this list which arm or denominator each percentage applies to, so these terms should not be assigned to an arm from this information. Serious adverse event counts and listed terms describe reported events; they do not by themselves establish causation or provide a complete assessment of comparative safety.
12. What the Result Does, and Does Not, Mean
The posted data establish that the registry contains descriptive Day 56 Total Mayo score summaries for both arms. The reported values are 2.7 for bertilimumab and 2.5 for placebo, with full ranges of 0.0 to 8.0 and 1.0 to 6.0, respectively. The record also gives outcome counts of 14 and 6. These details describe the posted results, but they do not constitute a statistical comparison of the assigned treatments.
They do not show the uncertainty around the mean summaries, because no confidence interval, standard error, or standard deviation is reported. They do not establish whether a between-arm contrast is statistically distinguishable from chance variation, because no inferential analysis is posted. They also do not show the shape of the distributions or the pattern of individual changes. A full range provides only the minimum and maximum, not the distribution between them.
The outcome counts do not explain how the results relate to the listed enrollment. The registry provides a modified intent-to-treat definition but does not report the flow of participants into the outcome analysis, reasons for non-inclusion, or missing-data handling. It is therefore not possible to judge whether the posted analysis population represents all randomized participants or how exclusions and missing measurements might affect the summaries.
The registry lists the study as terminated, but does not report why it was terminated. That status alone cannot be used to infer whether the trial stopped for safety, recruitment, efficacy, operational, or other reasons. No such explanation is present in the registry record. The record also does not provide the original sample-size rationale or an inferential statistical analysis plan.
In general, clinical interpretation of a treatment comparison depends on the estimated contrast, its uncertainty, the outcome’s clinical meaning, and the conduct and analysis of the trial. The posted arm summaries address only part of that picture. They should not be interpreted as proof that bertilimumab is beneficial, ineffective, equivalent to placebo, or harmful. Those conclusions would require evidence and analyses not reported in the registry record.
13. Why This Trial Matters Statistically
This trial is statistically notable because its registry record combines a defined clinical endpoint with limited inferential reporting. The primary outcome is a composite Total Mayo score measured from baseline to Day 56, and the record gives arm-level means and full ranges. Such summaries can describe the observed data, but they do not quantify the uncertainty of an estimated treatment contrast. The absence of a posted confidence interval or test result leaves the comparative precision unresolved.
The outcome counts also illustrate why analysis populations matter. The registry lists enrollment of 32, while the primary outcome summaries use 14 participants in the bertilimumab arm and 6 in the placebo arm. The stated modified intent-to-treat criteria clarify the intended analysis set, but the record does not explain the movement from enrollment to the analyzed outcome counts. A reader therefore cannot trace exclusions, missing follow-up, or the impact of the endpoint availability criteria.
Safety summaries use separate at-risk counts and should not be treated as if they were the same population used for the primary efficacy endpoint. The record’s safety figures are informative as counts, but do not provide the context needed to compare event risk reliably or attribute events to treatment. The serious-event term percentages are listed without enough information to identify the applicable arm or denominator.
More broadly, the record underscores the difference between a trial design and a report of statistical evidence. Randomization and masking describe design features; they do not substitute for a reported analysis, uncertainty estimate, missing-data strategy, or multiplicity plan. The study’s terminated status is recorded, but the reason is not. These gaps limit what can be concluded from the registry summaries without implying a particular explanation or outcome.
14. Limitations
- The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
- Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.
Several trial-specific limitations in the registry record constrain interpretation. The study is listed as terminated, and the reason is not reported in the registry record. The record gives a start date and primary completion date but does not describe the circumstances or timing of termination. It does not state whether the termination changed the planned enrollment, follow-up, or analysis.
The posted primary outcome counts are 14 for bertilimumab and 6 for placebo, while enrollment is listed as 32. The record does not reconcile these figures. Although it defines a modified intent-to-treat analysis set, it does not report participant flow, exclusions by reason, the number with missing Day 56 outcome data, or the handling of such data. The safety at-risk counts are different from the primary outcome counts, and their relationship is not explained.
The primary endpoint summaries report means and full ranges, but no confidence intervals, standard errors, standard deviations, or inferential comparison. Consequently, the precision of the arm summaries and the uncertainty of any between-arm contrast cannot be assessed. The registry does not provide a statistical analysis plan, model specification, covariate adjustment, assumption checks, or sensitivity analyses.
The record lists one secondary endpoint and gives serious-event term percentages without specifying the arm or denominator for each term. It does not report a multiplicity approach. The registry also does not state which trial personnel or participant groups were masked, despite identifying quadruple masking. These are limitations of the available registry information and do not establish that the trial lacked procedures or analyses that were not recorded.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Evaluation of Safety, Efficacy, Pharmacokinetic and Pharmacodynamic of Bertilimumab in Patients With Active Moderate to Severe Ulcerative Colitis — NCT01671956.
- Registry record last updated 2025-11-25; status last verified 2025-11.
- Results first posted 2025-11-25.
- Data retrieved from ClinicalTrials.gov on 2026-11-09.
- Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.
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18. Record Summary
NCT01671956 is a phase 2 randomized, quadruple-masked, parallel-group study of bertilimumab versus placebo in adults with active moderate to severe ulcerative colitis. Enrollment is listed as 32, and the study status is terminated. Bertilimumab was described as a 10 mg/kg intravenous infusion over 30 minutes; placebo was phosphate buffered saline by intravenous infusion over 30 minutes.
The primary endpoint was change from baseline in Total Mayo score at Day 56. The registry reports values of 2.7 for bertilimumab and 2.5 for placebo, with full ranges of 0.0 to 8.0 and 1.0 to 6.0. The primary outcome counts are 14 and 6. One secondary outcome is listed, and no analysis entries are posted. The registry does not report a treatment-effect confidence interval, inferential comparison, missing-data method, multiplicity plan, sample-size justification, or reason for termination.